Your browser does not support JavaScript! LEADER MEDICATED (MICONAZOLE NITRATE) POWDER [CARDINAL HEALTH INC.]
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RxNorm Names

LEADER MEDICATED (miconazole nitrate) powder
[Cardinal Health Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredient

Miconozole nitrate2%

Purpose

Antifungal

Uses

for the cure of most athlete's foot, jock itch and ringworm

Warnings

For external use only.

Do not use

on children under 2 years of age unless directed by a doctor

When using this product

do not get into eyes.

Stop use and ask a doctor if

if irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. ‚Äč

Directions

  • clean and dry affected area
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to spaces between toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks ; for jock itch, use daily for 2 weeks
  • if condition persists, consult a doctor
  • this product is not effective on scalp or nails

Other infomation

Product settles during shipment. Package contains full net weight.

Inactive ingredients

aldioxa, chloroxylenol, fragrance, imidurea, powdered cellulose, talc. Contains no starch

Questions

Call 1-866-964-0939

Box Label

Leader Medicated Miconazole Nitrate 2% PowderLeader Medicated Miconazole Nitrate 2% Powder Spray

LEADER MEDICATED 
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-653
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE1.42 g  in 71 g
Inactive Ingredients
Ingredient NameStrength
ALDIOXA 
CHLOROXYLENOL 
IMIDUREA 
POWDERED CELLULOSE 
TALC 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-653-1871 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/31/2010
Labeler - Cardinal Health Inc. (097537435)

Revised: 10/2012
 
Cardinal Health Inc.

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